| Methods |
Design: 2 x 2 factorial design (positive or negative consultation x placebo tablet or no tablet)
Purpose: examine the effect of positive consultation style and placebo tablet |
| Participants |
Patients: out‐patients attending a GP clinic with symptoms but without any physical signs and in whom no definite diagnosis could be made
Baseline comparability: yes |
| Interventions |
Placebo: tablet containing thiamine
Untreated: no tablet
Experimental:
‐positive consultation: firm diagnosis + good prognosis
‐negative consultation: no diagnosis and uncertain prognosis
(Co‐intervention: NS) |
| Outcomes |
Number of patients who improved
Doctor‐patient contact
Degree of communication
Number of days before improvement
Need for further treatment |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
|
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
Low risk |
N = 200 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
|
